Insulin Resistance, Obesity, Type 2 Diabetes
Conditions
Keywords
Type 2 Diabetes, Obesity, Insulin Resistance, Resveratrol, Inflammation
Brief summary
The main objective of this study is to investigate the effect of resveratrol (plant derived food supplement) on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo.
Detailed description
The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators and insulin resistance at the cellular and molecular level in obese non diabetic and type 2 diabetic subjects in vivo. This research will investigate the hypothesis that resveratrol, when given orally to obese and type 2 diabetic subjects induces a decrease in reactive oxygen species (ROS) generation and the pro-inflammatory transcription factor nuclear factor-kB (NF-kB) and the inflammatory mediators regulated by it. The hypothesis that resveratrol suppresses the high fat, high carbohydrate (HFHC) meal induced inflammatory and oxidative response, will also be investigated. This research will also investigate the hypothesis that resveratrol intake for 12 weeks improves insulin sensitivity by lowering the Homeostasis model assessment of insulin resistance (HOMA-IR), an index of insulin resistance and, that resveratrol intake will cause an increase in incretins.
Interventions
DRUGPlacebo
oral
DRUGResveratrol 40 mg oral three times a day
Drug
Resveratrol 500 mg oral once daily.
Sponsors
Kaleida Health
University at Buffalo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. 20 years of age and older 2. Healthy Obese subjects with BMI \> 30 3. Type 2 Diabetics with BMI \> 30 4. Subjects with good peripheral vein. 5. Subjects on statins, ACE inhibitors and thiazolidenediones will be allowed as long as they are on stable doses of these compounds and the dosage is not changed during the course of study.
Exclusion criteria
1. Subjects on any antioxidant medication 2. Patient on non-steroidal anti-inflammatory drug 3. On any agent with significant antioxidant properties. 4. History of drug or alcohol abuse 5. Any life threatening disease 6. Allergy to peanuts, grapes, wine, mulberries. 7. Pregnant women. 8. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four weeks. 9. Subjects on anticoagulants.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| NF-Kb | 12 weeks | To investigate the effect of resveratrol on ROS generation and the pro-inflammatory transcription factor NF-kB |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| GLP-1 | 12 weeks | To see whether Resveratrol leads to a greater stimulation of the incretin system and secretion/release of GIP and GLP-1 when compared to that following placebo |
Countries
United States
Outcome results
None listed